Clinical Trial of ReHeal Negative-Pressure Wound Therapy Glove
Abstract
Hands are complex and versatile, allowing us to perform intricate tasks with ease, but are vulnerable to trauma; full function—once lost—can be difficult to restore. Soft tissue trauma to the hand is debilitating and can significantly affect quality of life and independence. Treating a hand wound is inherently challenging due to the multiple tissue types (skin, nerves, bone, tendon, ligament, muscle) in close proximity, the high surface area-to-tissue volume ratio, and the complex tissue interactions required to provide normal function. Negative-pressure wound therapy (NPWT), delivering controlled vacuum suction, has been shown to be effective in healing many types of challenging wounds. It has the ability to enhance the healing response of the body in both chronic and acute wound beds. Currently, NPWT is most successfully applied to areas of the body with high tissue mass and few contours (e.g., leg, arm, abdomen) using foam sponges to fill wound cavities. The use of foam translates poorly to flexible areas like the hand: tissue volume is small; the surfaces are highly contoured; and the hand requires motion while healing to maintain or restore function. There is no cavity to pack in the thin tissue layers of the hand, and changing the dressing is complicated by tearing away new ingrowth into the foam sponge. Applying NPWT to the hand with current dressing methods requires surrounding the hand with foam and wrapping to create a seal. This immobilizes the hand, preventing the hand motion needed throughout recovery and leading to stiff, scarred skin and frozen joints. For the past several years, our team has been developing a transparent, flexible, self-sealing, non-adherent silicone dressing for the hand (the ReHeal Glove) that allows complete wound coverage, maintains hand flexibility during NPWT, and works with presently available Food and Drug Administration-approved NPWT vacuum pump devices. The ReHeal Glove’s novel sealing method and flexible material allows direct application of NPWT to the hand without restricting motion. The glove material is transparent, allowing clinicians to visually inspect the wound without removing the dressing and disturbing the wound bed. These features are intended to help patients with hand trauma recover quickly while maintaining hand dexterity and strength. In the proposed work, we plan to evaluate the feasibility of the ReHeal Glove by making stepwise improvements to the glove/pump system, using a small patient population with hand trauma to finalize the design. In future work, we will use results of this study to perform a comparative trial with a larger population to assess the glove’s ability to deliver useful NPWT to patients with soft tissue hand injuries for better functional outcomes. Our study monitor, the Chief of Hand Surgery at Walter Reed National Military Medical Center, will help ensure the applicability of the glove to militarily relevant injuries for the direct benefit of injured Service members. In addition, our home facility, Harborview Medical Center, which sees a heavy volume of hand trauma patients, will provide an outstanding opportunity to evaluate this system for the improvement of functional outcomes in both the military and civilian populations.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jul 16, 2019
- Source ID
- W81XWH1910247
Entities
People
- Christopher Allan
Organizations
- United States Army
- University of Washington